The present invention relates generally to smart pills, and more specifically, to companion diagnostics communicatively linked to the smart pill.
Swallowable capsules (also referred to as smart pills) have been evolving for almost half a century and are now helping uncover gastrointestinal (GI) tract mysteries in diagnostic and therapeutic applications. Additional information about swallowable capsule technology is found in “Swallowable-Capsule Technology” by Colm McCaffrey, Olivier Chevalerias, Cian O'Mathuna, and Karen Twomey, published by IEEE CS 1536-1268/08 © 2008 IEEE, which is herein incorporated by reference in its entirety.
In general, a swallowable capsule is a self-contained microsystem that performs a sensing or actuating function in the body. Usually, the system consists of the core components, such as sensors, signal conditioning, a power supply, central processing unit (CPU), and communication, encapsulated in a biocompatible material.
At one end of the chain are the sensors (or alternatively, actuators) that interface with the body. Sensors convert physical properties such as light, pressure, or temperature into electrical signals, while actuators perform the opposite function. The signal-conditioning block provides analog processing such as amplification and filtering to “clean” the detected signal. The system's brain, the CPU, digitizes the signal and might perform additional processing. The communication block can then transmit the signal to a receiver module outside the body.
The communication medium can be radio frequency (RF), a magnetic field (inductive coupling), or ultrasound. Finally, the power supply, based on either batteries or inductive coupling, provides energy for the system.
An article entitled “Philips' Smart Pill to Deliver Drugs” (Nov. 21, 2008) by Anni Shaer Levitt is herein incorporated by reference in its entirety. Philips' research division has developed a miniature pill that can administer drugs directly to specific places in the digestive tract. The new technology, named “iPill”, might enable new therapies for life-threatening disorders such as Crohn's disease, colitis, and colon cancer, along with assisting in the development of new drugs. Camera pills have come a long way since the first one was approved by the Federal Drug Administration (FDA) for diagnostic applications in 2000; ever since, most smart pills have been developed for this purpose only. Now, Philips is aiming to change this approach by developing a pill which can also take an active role in therapy. The iPill is a tiny capsule, similar to a camera pill, which was designed to be swallowed and then to pass through the digestive tract. Before the intake, it can be programmed to deliver medicine in a controlled fashion according to a pre-defined drug release profile which is to be created per patient and condition, and it is focused on treating conditions in different areas of the intestine. The iPill combines electronics with diagnostic and therapeutic properties in hopes of targeting almost any kind of drug to a specific location in the intestinal tract.
The device can determine its precise location in the intestinal tract by measuring the acidity of its surroundings. Different areas of the intestinal tract have specific pH values (the common measure for acidity). The stomach is highly acidic but the acidity drops dramatically right after the exit toward the intestine and continues to drop from the upper intestine onwards. Using these measures in combination with the data on the pill's transit times, the location can be easily determined. In addition, the pill measures the local temperature and reports measurements to an external receiver unit. When the iPill reaches an area defined in its drug-release profile, it begins accurately releasing the drug from the reservoirs using a microprocessor controlled pump.